Indications and uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
PANADOL
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:23
Label at a glance#
ProductPANADOL PM
Active ingredientACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor do not give to children under 12 years of age
Storage and handling
store at 25°C (77°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purposes
Pain reliever
Nighttime sleep-aid
Uses
- temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:
acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are taking
- the blood thinning drug warfarin
- sedatives or tranquilizers
When using this product
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
Stop use and ask a doctor if
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- pain gets worse or lasts more than 10 days
- redness or swelling is present
- any new symptoms appear
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed(see overdose warning)
- adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor
- do not give to children under 12 years of age
Other information (2 caplets)
- store at 25°C (77°F)
Other information (24 and 50 caplets)
- store at 25°C (77°F)
- close cap tightly after use
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, FD&C blue no. 1 aluminum lake, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions?
1-800-455-7139
Additional Information (2 caplets)
TAMPER-EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN
Fold Back And Tear To Open Or Use Scissors
Dist. by: GSK Consumer Healthcare,Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.
Additional Information ( (24 and 50 caplets)
Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Dist. by: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.
Principal Display Panel
NDC 0135-7021-03
Panadol
EXTRA STRENGTH
PM
ACETAMNOPHEN
Pain Reliever
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
50 CAPLETS
Tamper-Evident Feature:Do not use if printed inner safety seal under cap is broken or missing.
READ AND KEEP CARTON FOR COMPLETE INFORMATION
Dist. by: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks owned or licensed by GSK.
©2021 GSK or licensor.
B-0630-765-08 ORG
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | 4 |
| 1094718 | Panadol PM EXTRA STRENGTH 500 MG / 25 MG Oral Tablet | PSN | 4 |
| 1094718 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Panadol PM] | SBD | 4 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | 4 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | 4 |
| 1094718 | APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Panadol PM] | SY | 4 |
| 1094718 | Panadol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral Tablet | SY | 4 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-7021-01 | PANADOLPM | 50 in 1 CARTON | TABLET, FILM COATED | 50 | 4 | |
| 0135-7021-01 | PANADOLPM | 2 in 1 PACKET | TABLET, FILM COATED | 2 | 4 | |
| 0135-7021-02 | PANADOLPM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 | |
| 0135-7021-02 | PANADOLPM | 24 in 1 BOTTLE | TABLET, FILM COATED | 24 | 4 | |
| 0135-7021-03 | PANADOLPM | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | 4 | |
| 0135-7021-03 | PANADOLPM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- PANADOL PM
- acetaminophen and diphenhydramine HCl
- SILICON DIOXIDE
- CROSCARMELLOSE SODIUM
- FD&C BLUE NO. 1
- ALUMINUM OXIDE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POLYVINYL ACETATE
- HYPROMELLOSE, UNSPECIFIED
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
- ACETAMINOPHEN
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-7021 | 0135-7021-01, 0135-7021-02, 0135-7021-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | fe7cd1f2-9b00-4ded-99c2-8a152c71093c | 2024-02-06 | Warnings, Adverse reactions | 0135-7021-01 0135-7021-02 0135-7021-03 0135-7021 00135702101 00135702102 00135702103 10c195cf-3021-2052-e063-6294a90a1ea0 fe7cd1f2-9b00-4ded-99c2-8a152c71093c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.